Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Not yet enrolling; Phase 2

Conditions: Stage II-IIIB(N2) Non-small Cell Lung Cancer

Treatments: Drug: Nab-paclitaxel; Procedure: Surgery; Drug: Carboplatin; Drug: TQB2450; Drug: Pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT06109402

LungMate-019

Details and patient eligibility

About

For resectable non-small cell lung cancer, neoadjuvant immunochemotherapy plus adjuvant immunotherapy or adjuvant immunochemotherapy is usually used in clinical practice. However, it is unclear whether therapeutic strategy is superior. This trial aims to compare the efficacy and safety of these two strategies.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient shall sign the Informed Consent Form.
2. Aged 18 ≥ years.
3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-IIIB (N2) confirmed by imageological examinations (CT, PET-CT or EBUS).
4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
5. Life expectancy is at least 12 weeks.
6. At least 1 measurable lesion according to RECIST 1.1.
7. Patients with good function of other main organs (liver, kidney, blood system, etc.)
8. Patients with lung function can tolerate surgery;
9. Without systematic metastasis (including M1a, M1b and M1c);
10. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of immunotherapy (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
11. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of immunotherapy (whichever is later).

Exclusion criteria

1. Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
4. Participants who are allergic to the test drug or any auxiliary materials;
5. Participants with Interstitial lung disease currently;
6. Participants with active hepatitis B, hepatitis C or HIV;
7. Pregnant or lactating women;
8. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
9. Participated in another therapeutic clinical study;
10. Other factors that researchers think it is not suitable for enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Perioperative immunotherapy

Experimental group

Description:

In this arm, patients will receive neoadjuvant immunochemotherapy and adjuvant immunotherapy.

Treatment:

Drug: Nab-paclitaxel

Drug: TQB2450

Drug: Pemetrexed

Procedure: Surgery

Drug: Carboplatin

Adjuvant immunotherapy

Experimental group

Description:

In this arm, patients will receive adjuvant immunochemothrapy and immunotherapy

Treatment:

Drug: Nab-paclitaxel

Drug: TQB2450

Drug: Pemetrexed

Procedure: Surgery

Drug: Carboplatin